Maxim Danihel

In my role at Cytocell, I support the development and regulatory approval of diagnostic FISH probes by designing and executing verification studies aligned with ISO 13485 and IVDR standards. I generate and critically analyse data on assay performance (sensitivity, specificity, reproducibility, stability) and translate complex findings into clear, audit-ready reports and technical documentation.

Alongside hands-on lab work—including cell culture, harvest, FISH, and slide preparation—I contribute to the preparation of validation protocols, SOPs, and internal communications. My background in biomedical science and genetics enables me to bridge the gap between technical work and scientific writing, ensuring accurate, traceable, and compliant outputs across cross-functional teams.

Currently working as a Verification and Validation Analyst at Cytocell (Oxford Gene Technology), where I support the development of diagnostic FISH probes through experimental design, assay validation, and regulatory documentation in line with ISO 13485 and IVDR standards. Skilled in cell culture, metaphase preparation, FISH, karyotyping, and data analysis. Experienced in drafting validation protocols, technical reports, and SOPs for internal and regulatory use. I have worked with Cytocell for 1.5 years.

Previously worked for 1.5 years as Barista Maestro at Costa Coffee.

University of Kent – MSc Genetics – By Research Gained advanced training in molecular genetics and cytogenetics, including a research project on the development and application of multiprobe FISH devices for detecting chromosomal abnormalities in pigs and cattle. Developed practical skills in probe design, bacterial culture, DNA extraction, WGA, Nick translation, and PCR. Also trained and supervised students in cell culture and FISH techniques.

University of Kent – BSc (Hons) Biomedical Science – First Class – IBMS-accredited degree providing a strong foundation in clinical diagnostics, molecular biology, and human genetics. Completed a final-year literature review on CRISPR-Cas systems, critically comparing different Cas enzymes based on PAM requirements, specificity, and therapeutic potential.